Healthy and Affordable Protein Rich Foods for African Market

Healthy and Affordable Protein Rich Foods for African Market School Feeding Programs

This study is to gather information on school feeding programs and to measure the effect on linear growth and cognitive performance when providing a high-quality milk protein source or a combination of a high-quality milk protein source and rice proteins as a nutritional supplement to school children in Ghana. Children will receive a meal with a protein powder supplement with vitamins and minerals mixed into it. Participation is expected to last for 9 months.

1200 Children aged 6-7 years attending school will be enrolled throughout twenty primary schools (60 per school). Participants will be randomized to one of four groups: Control: Vitamins/minerals-200 mg premix contain the required micronutrients as per UNICEF recommendations.

For groups 1-3 the same vitamin/mineral mix will be used along with Group 1. Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the sugar lactose.

Group 2. Vitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk protein powder and the plant protein is a rice protein concentrate and the sugar lactose.

Group 3. Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein powder with the sugar lactose.

At baseline measurements-weight,height,mid-upper arm circumference,and body composition will be taken, fasting blood spot test will be administered to measure levels of Insulin and insulin like growth factor and other metabolic test, and computer based cognitive testing. Demographic information will be collected along with a dietary survey. Primary outcomes are cognitive performance on standardized tests and change in height-for-age z-score over the supplementation period, 9 months total. Questionnaires will be administered to collect demographic data and dietary information.

At the mid-point all measurements will be taken again and cognitive testing will be repeated.

At the end of the study all measurements will be taken again, cognitive testing repeated, blood spot samples taken again, and a short survey will be administered about the protein powders.

Study Overview

• Status: Completed
• Conditions: School Feeding Programs and Nutrition Supplements
• Intervention / Treatment: Dietary supplement: Vitamins/minerals; Dietary supplement: protein powder supplement

• Study Type: Interventional
• Enrollment (Actual): 1041
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Atebubu, Ghana
• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ghana school children between the ages of 6-9 years old

Exclusion Criteria:

• children with severe malnutrition
• chronic debilitation disease
• milk allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Vitamins/minerals-200 mg premix	Dietary supplement: Vitamins/minerals
Experimental: Group 1; Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the sugar lactose.	Dietary supplement: protein powder supplement
Experimental: Group 2; Vitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk protein powder and the plant protein is a rice protein concentrate and the sugar lactose.	Dietary supplement: protein powder supplement
Experimental: Group 3; Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein powder with the sugar lactose.	Dietary supplement: protein powder supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance on Cambridge Cognition tests (CANTAB)	Five tests created by Cambridge Cognition (CANTAB) will be selected and administered at enrollment, halfway through the intervention, and at the end of the intervention. The tests will examine visual memory pattern, recognition memory, test comprehension, rule acquisition, and attention set shifting. These tests will be administered on a Windows tablet by trained research staff. The participants will start by taking a practice test to get use to using the tablet and test format.	9 months
Change in height-for-age z score over the period of supplementation.		9 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: University of Ghana; Arla Foods

Publications and helpful links

General Publications

• Lee R, Singh L, van Liefde D, Callaghan-Gillespie M, Steiner-Asiedu M, Saalia K, Edwards C, Serena A, Hershey T, Manary MJ. Milk Powder Added to a School Meal Increases Cognitive Test Scores in Ghanaian Children. J Nutr. 2018 Jul 1;148(7):1177-1184. doi: 10.1093/jn/nxy083.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: HAPFAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual data available